“You are not going to change what we do, you’re not going to change our determination to make these patients better. I see these patients, I know these patients, I value these patients, I’ve looked after them for years. I’ve seen them after the procedure, the vast majority are improved.”

The above quote could be a reference to just about any fringe medical treatment. It is partly an expression of faith in anecdotal experience over scientific evidence. It is partly the fallacy of justifying a treatment because it is needed – whereas the real question is whether or not the treatment works. It is an attempt to justify specific claims with compassion, as if the person quoted cares more for the health of their patients than those who might be skeptical of their claims. And it is an expression of stubbornness – I know the truth, so don’t confuse me with evidence and logic.

Is this person talking about acupuncture? Perhaps they run a stem cell clinic in China, India or somewhere outside the reach of regulation. Or maybe they are defending hyperbaric oxygen therapy for unproven indications, like autism. It could be anything, because this sentiment is the standard mantra of the dubious practitioner, practicing outside the bounds of science-based medicine.

The quote is from Dr. Tom Gilhooly, a GP who runs Essential Health, a clinic in the UK that offers the liberation procedure for presumed CCSVI (chronic cerebrospinal venous insufficiency). Gilhooly is defending his practice to the BBC, after a healthy investigator, Sam Smith, presented to his clinic and paid to have a screening procedure performed – which diagnosed her with CCSVI.

I wrote about CCSVI last year – this is a controversial claim by vascular surgeon Dr. Paolo Zamboni, who believes that multiple sclerosis (MS) is caused by venous insufficiency in the brain. The liberation procedure uses balloons to open up the allegedly blocked veins, and in some cases stents are place to keep the veins open. Since my last reporting there have been several more attempts to replicate Zamboni’s research – all negative. This study compares MS patients to patients with other neurological disease and healthy controls, and found no significant difference in the prevalence of signs of venous insufficiency. Another study found that venous pressure is not different in MS patients vs normal controls Yet another study found a lack of association between CCSVI and HLA DRB1*1501 in MS patients, which is a genetic variant that carries an increased risk of developing MS.

The bottom line is that, so far, it is not looking good for CCSVI being a real disorder that is associated with, let alone a major cause of, MS.

Further – there is no clinical data (other than anecdotes) to demonstrate that the liberation procedure is a safe and effective treatment for any subtype of MS. But the claims for the treatment are dramatic, there is impressive-sounding anecdotal evidence of benefit (because there always is – no matter what the alleged treatment), and in many patients MS is a debilitating and progressive disease that does not always respond to treatment. In other words, there are desperate patients out there, and the combination of desperation and dramatic claims leads to people seeking treatment, despite the lack of scientific evidence.

These situations require thoughtful regulation in order to ensure that patients are not exploited (even by well-meaning practitioners, and we certainly cannot assume that everyone offering an expensive treatment is going to be well-meaning). The system needs to allow for some flexibility within the standard of care, and certainly for experimentation to advance the science of medicine. But this has to be balanced with the needs of informed consent and ethical practice and research.

This can be a difficult balance to strike. But as some countries are struggling to achieve the optimal balance of freedom and protection at the edge of scientific knowledge, medical tourism is undercutting such efforts.

The BBC reports, for example, that while the NHS does not cover the liberation procedure, thousands of patients have already gone overseas to have the procedure. There are reports of at least two deaths from the procedure, so it is not without its risks.

Clearly, use and demand for the liberation procedure has raced ahead of the evidence, which is mostly negative. More research is needed to put this claim to bed, or perhaps discover a more limited role for this syndrome and its treatments. But there is certainly an insufficient basis to offer the procedure outside of an ethically designed and executed clinical trial.

This is not an isolated example, nor is it even the worst example. Stem cell tourism appears to be a much greater problem, with patients (victims) spending tens or hundreds of thousands of dollars to fly around the world to get unknown cocktails (claimed stem cells) injected into them without any reasonable expectation of benefit, but with clear risks.

We are seeing the globalization of high-tech quackery. Current regulatory systems are not designed to address this problem All we can do is ask countries in which these clinics thrive to crack down, but there is a reason why such clinics are set up in these countries to begin with.

Meanwhile we can educate the public, and potential victims, about the evidence and the dangers. But information is often impotent against the power of desperation.

17 thoughts on “The Dark Side of Medical Globalization”

There will always be desperate patients, always be quacks, always be venues where the two can meet. The catalyst that enables the reaction is ignorance of science and ignorance of medicine.

A recent episode of SGU mentioned that understanding of basic scientific concepts was improving in the US and now had reached the breathtaking level of perhaps 28% of the population.* (Don’t feel too bad, globally only Sweden at 35% scored better.)

This leaves a fertile field for quacks and their enablers in the media. Most troubling is the embrace of quackery by the medical establishment in the US. Americans are getting a mixed message from the very institutions that should be the bulwark against woo.

*I don’t know if this was the source for SGU. My information came from “The Surprising Effectiveness of College Scientific Literacy Courses”, Hobson, The Physics Teacher, 2008 Vol 46, courtesy University of Google.

Re-reading it now, it definitely seems like they paint Zamboni to be the rebel doc. who’s “sticking it to the man” by studying this radical new theory. They even interview neurologists at places like the Cleveland Clinic about the procedure – and they seem to indicate that further research into the procedure would be great both for increasing knowledge about MS as well as how the venous system contributes to neuropathology. It seems though that an expert in neuropathology would already have a some understanding of how substances or blood (or lack thereof) traveling in the venous system could contribute to setting up or progressing the conditions found in MS. Where are these experts in these interviews? In other words, where are the people who would be able to give some sort of pathophysiologic explanation? Seems like there aren’t any.

At one point though I had to laugh when I read what one MS patient said, “”At first, I was very skeptical. But anecdotal reports started coming through of almost miraculous results from it.…So, I decided, you know, hey it was worth a shot,” Stecker says.”
*sigh

I was surprised that we haven’t heard more from you on this issue, seeing as it is your area of expertise. However, I attended a presentation on CCSVI last week and found out that this procedure is almost a non-issue in the U.S. (I am in Canada). There have been numerous news stories on this issue here that have whipped patients and healthcare critics into a frenzy (the prevalence of MS is much higher here as well). I work in an MS Clinic and hear stories every week about CCSVI and how it is being suppressed by neurologists and drug companies in order to protect their revenue stream.

An interesting debate emerged at the end of the presentation regarding our course of action as healthcare professionals/scientists. The room was about evenly split on whether to carry on with trials looking for an association between CCSVI and MS, or if a large-scale RCT should be done now in order to address the issue once and for all. I would be interested in your perspective on the issue. The argument for an immediate RCT boiled down to an admission that – yes, it skirted the normal process in science-based medicine, however anything less than a properly conducted, large-scale trial would be unimpressive to MS patients and would not sway their opinion. As I mentioned, things are a little trickier north of the border as government officials are even weighing in on what trials should be conducted and whether or not the procedure should be funded.

??? Is there some genetic reason for this or some other explanation? I did a (very) little research and found that indeed Canada, UK and Sweden (among countries with reliable data) have a high incidence of MS.

The prevalence is higher in northern latitudes and the general understanding is that it increases with distance from the equator. A recent study (if memory serves) challenges this assertion and I don’t think it holds globally (but definitely in NA, Europe).
The obvious and hot-button association is of course sunlight exposure and by extension vitamin D levels, but there is nothing definitive about this. Genetics could also play a role, the disease is also more common in caucasians.

Interesting. A comparison of MS rates between, say, the Pacific Northwest and the Southeastern US might shed light on the possible relationship between sunlight and MS. There would still be some issues as the populations and genetics between the two regions are by no means homogenous. Still might be interesting.

MS incidence is also higher at southern latitudes, at least within the European population of New Zealand, where the incidence increases with distance from the equator.

Since many of the original European settlers to southern New Zealand originated from higher incidence areas of Scotland it is also possible that genetics are contributing to the distribution according to latitude.

Incidence of MS within indigenous Maori is very low but not zero. I have no knowledge of any research on incidence within Maori according to latitude.

Once again, thank you for bringing a rational perspective to the CSSVI debate, Dr. Novella. As a member of the online MS community, I have experienced first-hand the impotence of fact when it’s confronted by power of desperation. I am disturbed by the fact that some of these clinics are operating right here in the US and Canadian MSers are coming down to be scanned and treated by American doctors. How can this be when CCSVI hasn’t been recognized in the US? Are these doctors committing fraud? I wish I could say that one day there will be a large enough, randomized, double-blinded and controlled study that will be the final word, but I’ve seen enough to know that if the results are anything but positive, it will never be accepted by the most ardent and vocal supporters of liberation.

Out of all the things I could fear about MS, I never thought the thing I’d fear the most would be the desperation and willful ignorance of some my fellow MSers.

@inconscious- Thanks for the link to the NPR article.I read and listened to it,and I got a different impression than what you described.I thought that they were pretty fair in their reporting.Though they didn’t condemn the procedure outright,there were several passages that might give a reader pause about CSSVI,including this:

But it didn’t work. Although the doctor who treated him in New York found a significant blockage, he was unable to correct it, Stecker says.
Still, some would say Stecker was lucky. Many desperate patients have spent their life savings flying overseas to have the procedure, only to have it fail a few months later. Others elect to have tiny metal tubes, known as “stents,” placed in the veins to hold them open and have suffered serious complications, including life-threatening blood clots. Several patients have even died as a result.

I’m afraid that mr.grieves is right, at this point the CCSVI circus has got so out of control that only large-scale clinical trials are likely to end the hysteria surrounding it. If he thinks that things are bad in Canada he should try living in Italy, where the Minister of Health has gone against the advice of his own scientific advisory committee to push for the treatment to be introduced.

It’s ironic that the CCSVI advocates constantly deploy the pharma shill gambit against neurologists who urge caution on “liberation therapy” while the surgeons performing the surgery in a number of private clinics arounfd the world are making a tidy sum from CCSVI. This blog post on the Panacie or Hygie blog (which has a lot of posts on CCSVI research) exposes one clinic in Poland which sees over a thousand patients every year (all adding up to several million dollars worth of trade) as using diagnostic procedures that don’t even come up to the minimal standards developed by Zamboni.

The post also points out that Zamboni is a consultant for Esaote, a form that manufactures the echo doppler ultrasound scanner described as “the only product designed for the diagnosis of CCSVI.” I doubt that his services come for free!

As more and more clinical studies are performed it is becoming more and more clear that CCSVI is not the cause of MS. Another study published in J Neurol Neurosurg Psychiatry last month (Mayer CA et al. 2011), using the transcranial doppler technique recommended by Zamboni along with other measurments, found no evidence for CCSVI in MS patientshttp://jnnp.bmj.com/content/early/2011/02/04/jnnp.2010.231613.long

Even more tellingly another study in Annals of Neurology (Baracchini et al. 2011) found no evidence of CCSVI in people with clinically isolated syndormes (CIS) suggestive on MS. Diagnosis of CIS often preceeds diagnosis with MS, so if CCSVI were a cause of MS you would expect to see it in people at the earlier stages of the disease.

As a recent commentary in AJNR points out (Filippi M et al 2011, PMID: 21292801) the changes observed in the extrancranial veins of people with MS and identified as CCSVI may well be a consequence of lower vascular input that causes the veins to collapse. This strikes me as a more credible explanation than Zamboni’s theory.

A minor point, perhaps, but people in the Northwest get plenty of sunlight, in spite of winter cloudiness. Because the weather is fairly mild, they go outside a lot more than, say, people in Wisconsin or Michigan, who are almost completely covered up even when they do go out. People in the Northwest, in contrast, often wear shorts in February–and there are many sunny days in February.

“I’m afraid that mr.grieves is right, at this point the CCSVI circus has got so out of control that only large-scale clinical trials are likely to end the hysteria surrounding it.”

The question is – would even a large-scale RCT be enough to convince patients not to pursue this treatment (or better yet, physicians not to offer it). I am not optimistic that this will be the case. Funding would also be an issue, obviously there could be no drug company involvement but at this point even the MS Society (in Canada anyway) may be viewed as a tainted source.

Regarding the situation in Italy – I can imagine it can only be worse. Someone threw up a figure showing google searches per captia for CCSVI/liberation treatment by country after Zamboni started his media blitz last November. Canada and Italy spiked off the chart and have continued since, all of the other countries barely registered.